1. ICH Drug development guidelines are included in, explain why: a. Q7 b. Q8 c.
ID: 205713 • Letter: 1
Question
1. ICH Drug development guidelines are included in, explain why: a. Q7 b. Q8 c. Q7, Q8, and Q9 d. Q8 and Q10 2. CFR 210 and 211 do apply to the manufacture of, explain why a. Drugs and biotech finished products b. Drugs and biotech finished products as well as to APls c. APIs and drug finished products d. Drugs and biotech finished products as well as to APls and intermediates 3. Describe briefly the following operations in the Pharmaceutical Manufacturing Process: a. Powder Blending b. Milling c. Granulation d. Hot melt extrusion e. Production of dosage forms 4. What is a GMP considerations in the pharmaceutical industry? Explain briefly this concepts 5. What is the difference between unit operations and unit processes?. Give an example 6. Give three advantages and disadvantages of pneumatic conveyors used in Pharmaceutical Industry 7. What this mean CAPA? And how is used in Q10 foe pharmaceutical or biopharmaceutical manufacturing process? 8. What is the purpose of CAPA in the Pharmaceutical/Biopharmaceutical Manufacturing Process? 9. What is a clean room? and what are the considerations for an air highly filtrated 10. List four examples of types of materials used in cleanrooms. Explain 11. Give three methods used for cleaning a cleanroom, make a brief description 12. What type of water is used in the washers of a cleanroom laundry? 13. Why are watches and rings generally removed before entering the cleanroom?Explanation / Answer
Q5) differences between unit operation and unit process
Unit operations
- In unit operations only physical changes occur takes place. example evaporation, drying, distillation etc
- Unit operations are considered as primary treatment because it involves only physical forces.
Unit processes
- In unit process chemical changes takes place for example Nitration, Oxidation, Reduction etc
- Unit process are considerd as secondary treatment because it includes all treatment methods, brought about by chemical or biological reactions.
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